Effect of PCI on Clinical Prognosis of Chronic Coronary Artery Occlusion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 258
- Locations
- 1
- Primary Endpoint
- major adverse cardiac cerebrovascular events (MACCE)
Study Overview
Brief Summary
Coronary chronic total occlusions (CTOs) are considered to increase the risk of adverse clinical outcomes. The purpose of this study was to evaluate whether long-term clinical outcomes could be improved by successful percutaneous coronary intervention (PCI) over optimal medical therapy (OMT) in CTO patients.
Detailed Description
patients with CTO lesions undergoing PCI at the First Affiliated Hospital of Nanjing Medical University from January 2011 to December 2017 were enrolled. After someone were excluded due to CABG surgery, patients who met the enrollment criteria were divided into successful CTO-PCI group and CTO-OMT group based on the treatment received. The study primary endpoint was major adverse cardiac cerebrovascular events (MACCE), including cardiac death, recurrent myocardial infarction, unplanned revascularization, and stroke. The secondary endpoint was all-cause death.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with at least one coronary CTO lesion at our hospital in between January 2011 and December 2017
Exclusion Criteria
- •(1) patients with ST-segment elevation myocardial infarction (STEMI)
- •(2)a history of coronary artery bypass grafting (CABG)
- •(3) cardiogenic shock
- •(4) malignant tumor. Patients were referred for PCI based on CTO-related symptoms or evidence of viability, or corresponding ischemia in the area of the CTO artery.
Arms & Interventions
CTO-PCI group
successful percutaneous coronary intervention (PCI)
Intervention: PCI (Procedure)
CTO-PCI group
successful percutaneous coronary intervention (PCI)
Intervention: OMT (Drug)
CTO-OMT group
optimal medical therapy (OMT)
Intervention: OMT (Drug)
Outcomes
Primary Outcomes
major adverse cardiac cerebrovascular events (MACCE)
Time Frame: January 2011 to December 2023
including cardiac death, recurrent myocardial infarction, unplanned revascularization, and stroke.
Secondary Outcomes
- all-cause death(January 2011 to December 2023)
Investigators
Chen Leilei
Director
The First Affiliated Hospital with Nanjing Medical University